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NCT Number: NCT04777032

The Danish Comorbidity in Liver Transplant Recipients Study

Background:

Liver transplantation is the only curative treatment for patients with end-stage liver disease. Short-term survival has improved due to improved surgical techniques and greater efficacy of immunosuppressive drugs. At present, the 10-year survival after liver transplantation is 60%, but long-term survival has not improved to the same extent the short-term survival. In addition to liver- and transplant-related causes, comorbidities such as cardiovascular, pulmonary, renal, and metabolic diseases have emerged as leading causes of morbidity and mortality in liver transplant recipients.

The objective of this study is to assess the burden of comorbidities and identify both liver- and transplant-related risk factors as well as traditional risk factors that contribute to the pathogenesis of comorbidity in liver transplant recipients.

Methods/design:

The DACOLT study is an observational, longitudinal study. The investigators aim to include all adult liver transplant recipients in Denmark. Participants will be matched by sex and age to controls from the Copenhagen General Population Study (CGPS) and the Copenhagen City Heart Study (CCHS). Physical and biological measures including blood pressure, ancle-brachial index, spirometry, exhaled nitric oxide, electrocardiogram, transthoracic echocardiography, computed tomography (CT) angiography of the heart, unenhanced CT of chest and abdomen and blood samples will be collected using uniform protocols in participants in CGPS, CCHS and DACOLT. Blood samples will be collected and stored in a research biobank. Follow-up examinations at regular intervals up to 10 years of follow-up are planned.

Discussion:

There is no international consensus standard for optimal clinical care or monitoring of liver transplant recipients. The study will determine prevalence, incidence and risk factors for comorbidity in liver transplant recipients and may be used to provide evidence for guidelines on screening and long-term treatment and thereby contribute to improvement of the long-term survival.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Liver Transplantation Comorbidities and Coexisting Conditions

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aalborg University Hospital, Aalborg, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Liver transplanted
  • age between 20 and 100 years
  • be able to understand the study information in either Danish or English and to be able to provide an informed consent

Exclusion criteria

  • none

Treatment and study plan

Primary outcomes

  1. Prevalence of coronary artery disease

    Time frame: Baseline cross-sectional data

    Assessed by coronary CT angiography

  2. Change in Coronary artery disease

    Time frame: 10 years follow-up

    Assessed by coronary CT angiography

  3. Cardiac function

    Time frame: Baseline cross-sectional data

    Determined by transthoracic echocardiography

  4. Change in Cardiac function

    Time frame: 10 years follow-up

    Determined by transthoracic echocardiography

  5. Cardiac structure

    Time frame: Baseline cross-sectional data

    Determined by transthoracic echocardiography

  6. Change in cardiac structure

    Time frame: 10 years follow-up

    Determined by transthoracic echocardiography

  7. Cardiac structure

    Time frame: Baseline cross-sectional data

    Assessed by cardiac computed tomography (CT)

  8. Change in Cardiac structure

    Time frame: 10 years follow-up

    Assessed by cardiac computed tomography (CT)

  9. Cardiac function

    Time frame: Baseline cross-sectional data

    Assessed by cardiac computed tomography (CT)

  10. Change in Cardiac function

    Time frame: 10 years follow-up

    Assessed by cardiac computed tomography (CT)

  11. Dynamic lung function indices assessed by spirometry

    Time frame: Baseline cross-sectional data

    FVC and FEV1 assessed by spirometry

  12. Change in Dynamic lung function indices assessed by spirometry

    Time frame: 10 years follow-up

    FVC and FEV1 assessed by spirometry

  13. Renal function

    Time frame: Baseline cross-sectional data

    Estimated glomerular filtration rate

  14. Change in Renal function

    Time frame: 10 years follow-up

    Estimated glomerular filtration rate

  15. Metabolic diseases

    Time frame: Baseline cross-sectional data

    Prevalence of Diabetes

  16. Metabolic diseases

    Time frame: 10 years follow-up

    Change in Diabetes

  17. Metabolic diseases

    Time frame: Baseline cross-sectional data

    Prevalence of Dyslipidaemia

  18. Metabolic diseases

    Time frame: 10 years follow-up

    Change in Dyslipidaemia

Secondary outcomes

  1. Prevalence of Depression

    Time frame: Baseline cross sectional data

    Major Depression Inventory (MDI): A depression questionnaire. The questionnaire consists of the ten symptoms contained in the World Health Organization WHO's depression demarcation. The patient's completed questionnaire is scored using a scoring key.

    When MDI is used as a rating scale in the same way as the Hamilton scales, then the sum of the ten questions indicates the degree of depression. The theoretical score range is from 0 (no depression) to 50 (maximum depression).

    Mild depression: MDI total score from 21 to 25 Moderate depression: MDI total score from 26 to 30 Severe depression: MDI total score of 31 or higher

  2. Change in Depression

    Time frame: 10 years follow-up

    Major Depression Inventory (MDI): A depression questionnaire. The questionnaire consists of the ten symptoms contained in the World Health Organization WHO's depression demarcation. The patient's completed questionnaire is scored using a scoring key.

    When MDI is used as a rating scale in the same way as the Hamilton scales, then the sum of the ten questions indicates the degree of depression. The theoretical score range is from 0 (no depression) to 50 (maximum depression).

    Mild depression: MDI total score from 21 to 25 Moderate depression: MDI total score from 26 to 30 Severe depression: MDI total score of 31 or higher

  3. Fracture risk

    Time frame: Baseline cross sectional data

    FRAX® score. The FRAX® tool has been developed to evaluate fracture risk of patients. It is based on individual patient models that integrate the risks associated with clinical risk factors.

    The FRAX® algorithms give the 10-year probability of fracture. The output is a 10-year probability of hip fracture and the 10-year probability of a major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture).

  4. Change in Fracture risk

    Time frame: 10 year follow-up

    FRAX® score. The FRAX® tool has been developed to evaluate fracture risk of patients. It is based on individual patient models that integrate the risks associated with clinical risk factors.

    The FRAX® algorithms give the 10-year probability of fracture. The output is a 10-year probability of hip fracture and the 10-year probability of a major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture).

  5. Obstructive pulmonary disease

    Time frame: Baseline cross sectional data

    Nitric oxide in exhaled breath

  6. Obstructive pulmonary disease

    Time frame: 10 year follow-up

    Change in Nitric oxide in exhaled breath

  7. Prevalence of Peripheral artery disease

    Time frame: Baseline cross sectional data

    Ankle-brachial-index (ABI) is measured using a Doppler meter by determining the systolic pressure in the arm and ankle.

  8. Change in Peripheral artery disease

    Time frame: 10 years follow-up

    Ankle-brachial-index (ABI) is measured using a Doppler meter by determining the systolic pressure in the arm and ankle.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

The Danish Comorbidity in Liver Transplant Recipients Study (DACOLT) - a Non-interventional Prospective Observational Cohort Study

Acronym: DACOLT

Important dates

Study start
2021
Primary completion
2033
Study completion
2043
First posted
Mar 2, 2021
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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